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The DESIO (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The DESIO (polymacon) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Disposable Wear:

Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

The DESIO soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. All lenses containing dioptric powers outside +/- 10.00 D and toric lenses are lathe-cut to specified Rx. The DESIO soft contact lenses are fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The nonionic lens material, (polymacon) is a hydrophilic polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The (polymacon) name has been adopted by the United States Adopted Names Council (USAN).

DESIO lenses are available clear or tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: D&C Yellow 10, Titanium Dioxide, Iron Oxide (Red), [Phthalocyaninato(2-)] Copper, Phthalocyanine Green, Carbazole Violet, Reactive Blue 19, C.I. Reactive black 5.

Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.0 mm.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The physical properties of the lens are: Refractive Index 1.43, Light Transmission (clear) greater than 96%, Light Transmission (tinted) greater than 96% (at region corresponding to pupil); Opaque or 0-10% (at region corresponding to iris), Surface Character hydrophilic, Water Content 38±2%, Specific Gravity 1.17 (hydrated), Oxygen Permeability 12.48 x 10-11 (cm²/sec)(mlO2)/(ml x mmHg @ 35°C)) (revised Fatt method).

The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in spherical and toric configurations with the following features and properties: Chord Diameter: 12.80 mm to 15.00 mm, Center Thickness: 0.050 mm to 0.210 mm, Base Curve: 8.0 mm to 9.8 mm, Power Range Cast-molded: -10.00D to +10.00D in 0.25D steps, Lathe-cut: -20.00D to -10.00D & +20.00D to +10.00D in 0.25D steps, Cylinder Power (Toric): -0.25D to -4.00D in 0.25D steps (lathe-cut), Cylinder Axis (Toric): 10° to 180° in 10° steps.

DESIO lenses are supplied in blister packages with a base made from polypropylene and a laminated foil seal on top. The lenses are supplied sterile in Polyhexamethylene Biguanide (PHMB) containing saline solution. Blister package labeling is printed with the appropriate lot numbering, expiration dating, and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

The provided document is a 510(k) summary for the DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving that it meets specific acceptance criteria in a clinical study against a hard defined set of endpoints.

Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically associated with a new technology demonstrating its performance against a predefined benchmark. Instead, it focuses on demonstrating equivalence to an existing device.

However, I can extract information related to the device's properties and the basis for its safety and effectiveness claims.

Here's a breakdown of the requested information based on the provided document, acknowledging the type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, there are no explicit "acceptance criteria" in the sense of predefined performance thresholds for a novel device's efficacy. The acceptance is based on demonstrating substantial equivalence to a predicate device in terms of intended use, materials, physical construction, and safety/effectiveness.

The table below summarizes key physical properties of the DESIO lenses, which are implicitly acceptable because they are equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document explicitly states: "The clinical performance of the (polymacon) lens material has been previously established, and therefore was not required for this 510(k)." This indicates that NO new clinical test set data was collected for this specific 510(k) submission to demonstrate performance beyond the inherent properties of the material and device design. The "testing" referred to primarily consisted of non-clinical (in vitro and in vivo toxicology, biocompatibility, stability) studies.
• Data Provenance: Not applicable for a new clinical test set. The non-clinical studies (toxicology, microbiology, chemistry, shelf-life stability) were conducted by "Several laboratories under Good Laboratory Practice regulations" (page 7). The country of origin for these labs is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable as no new clinical test set was used for performance validation in this 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable as no new clinical test set was used for performance validation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This type of study (comparing human readers with and without AI assistance) is not relevant for a contact lens approval, which focuses on physical, material, and biocompatibility properties, and visual correction.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This is not an AI or algorithm-based device.

7. Type of Ground Truth Used

• For the non-clinical studies: The "ground truth" would be established by standard scientific and regulatory methods for evaluating sterility, toxicity, biocompatibility, and physical properties (e.g., meeting established chemical and biological markers, physical measurements, and stability over time).
• For the overall device approval: The "ground truth" for substantial equivalence is derived from the established safety and effectiveness profile of the predicate device (ISENS by Vision Science Co., Ltd., 510(k) number; K132714) and the scientific understanding of the polymacon material.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable as there is no "training set" for this device.

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